Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings

DALLAS, April 04, 2008, 2008 /PRNewswire/ -- Data from five studies sponsored by Ortho Biotech Products, L.P. will be presented at the National Kidney Foundation (NKF) 2008 Spring Clinical Meetings from April 2 - 6, 2008; three utilization studies involve PROCRIT(R) (Epoetin alfa).

The data include studies that compare drug utilization patterns and costs of PROCRIT (EPO) and darbepoetin alfa (DARB), evaluate medical costs related to chronic kidney disease (CKD) patients with hypertension or diabetes, and show the impact on hemoglobin (Hb) control using a software-based management tool. These retrospective analyses used data from actual clinical practice.

Data on Drug Utilization Patterns and Costs of Epoetin Alfa and Darbepoetin Alfa

    -- Abstract:  Assessment of Drug Utilization Patterns and Costs for

       Erythropoietic Stimulating Agents in Patients with Chronic Kidney

       Disease

       Patrick Lefebvre, M.A., Groupe d'analyse, Ltee, Montreal, Quebec,

       Canada

       A retrospective analysis of medical claims was conducted using the

       Ingenix Impact National Managed Care Database to examine recent EPO and

       DARB treatment patterns and corresponding drug costs in newly-initiated

       CKD patients treated with EPO (n=1,110) or DARB (n=723) not receiving

       dialysis. Mean cumulative dose was used to calculate drug costs based

       on October 2007 wholesale acquisition unit prices.


    -- Abstract:  Drug Utilization and Cost Considerations of Predialysis

       Chronic Kidney Disease Patients Receiving Erythropoietic Stimulating

       Agents Through Pharmacy Benefits

       Francois Laliberte, M.A., Groupe d'analyse, Ltee, Montreal, Quebec,

       Canada

       A retrospective analysis of pharmacy claims using the PharMetrics

       Patient-Centric Database, which represents approximately 85 managed

       healthcare plans, was conducted to compare drug utilization patterns

       and costs of a newly-initiated, managed care predialysis chronic kidney

       disease population receiving EPO (n=1,066) or DARB (n=375) through a

       pharmacy benefit.  Drug cost was based on cumulative dose and October

       2007 wholesale acquisition cost.


Data on Medical Costs Related to Chronic Kidney Disease Patients with Hypertension or Diabetes

    -- Abstract:  Medical Costs of Chronic Kidney Disease in Patients with

       Diabetes:  A Managed Care Perspective

       Francois Laliberte, M.A., Groupe d'analyse, Ltee, Montreal, Quebec,

       Canada

       A retrospective analysis of medical claims and laboratory data from a

       large managed care database was conducted to quantify the incremental

       direct healthcare costs of CKD in patients with diabetes.  Analyses

       compared diabetes patients who developed CKD versus those who did not

       for yearly direct healthcare costs, which consisted of outpatient

       services, inpatient services and pharmacy dispensing claims.  A total

       of 30,480 patients with diabetes were identified, of whom 859 developed

       CKD during the study period.


    -- Abstract:  The Effect of Anemia in Hypertensive Patients with Chronic

       Kidney Disease:  Hospital Costs and Length of Stay

       Sandra Sulsky, M.P.H., Ph.D., ENVIRON International Corporation,

       Amherst, MA

       A retrospective analysis of hospital discharge records from the 2004

       Nationwide Inpatient Sample of the Hospital Cost and Utilization

       Project, which comprises approximately 90 percent of all hospital

       discharges in the U.S., was conducted to determine the effect of anemia

       on hospital costs and length of stay in hypertensive patients with CKD.

       Analyses were adjusted for age, gender, income level, severity of

       disease, and hospital characteristics to control for the confounding

       effects of anemia, CKD and a combination of both on study outcomes.


Data on the Impact on Hemoglobin Control Using a Software-Based Management Tool

    -- Abstract:  Use of Epoetin Alfa in Maintaining Hemoglobin Control

       Through a Software-Based Management Tool in a Community Nephrology

       Setting

       Craig Kleinmann, D.O., Nephrology Associates, Mobile, AL

       A retrospective, observational chart review from a large U.S.

       nephrology clinic was conducted in May 2007 to analyze the impact of

       EPO on mean Hb over time as well as subsequent dose holds in anemic

       non-dialysis CKD patients in a community practice setting using

       TrakAnemia, a software-based tool.  Eighty-seven patients who had a

       documented diagnosis of anemia due to non-dialysis CKD, initiated EPO,

       and had greater than or equal to six months of follow-up data were

       included in the final analysis.


About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

    Cancer:

    -- ESAs shortened overall survival and/or time-to-tumor progression in

       clinical studies in patients with breast, non-small cell lung, head and

       neck, lymphoid, and cervical cancers when dosed to target a hemoglobin

       of greater than or equal to 12 g/dL.

    -- The risks of shortened survival and tumor progression have not been

       excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.

    -- To minimize these risks, as well as the risk of serious cardio- and

       thrombovascular events, use the lowest dose needed to avoid red blood

       cell transfusions.

    -- Use only for treatment of anemia due to concomitant myelosuppressive

       chemotherapy.

    -- Discontinue following the completion of a chemotherapy course.


Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

Contraindications

PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.

    Additional Important Safety Information

    -- The dose of PROCRIT should be titrated for each patient to achieve and

       maintain the following hemoglobin levels:

       * Chronic renal failure patients - hemoglobin levels between 10 to 12

         g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL

         despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and

         ADMINISTRATION in the PROCRIT Prescribing Information.

       * Cancer or HIV patients - the lowest hemoglobin level sufficient to

         avoid transfusion and not to exceed 12 g/dL.

    -- Monitor hemoglobin regularly during therapy, more frequently following

       a dosage adjustment or until hemoglobin becomes stable.

    -- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or

       without other cytopenias, associated with neutralizing antibodies to

       erythropoietin have been reported in patients with chronic renal

       failure receiving PROCRIT by subcutaneous administration.  If any

       patient develops a sudden loss of response to PROCRIT, accompanied by

       severe anemia and low reticulocyte count, and anti-erythropoietin

       antibody-associated anemia is suspected, withhold PROCRIT and other

       erythropoietic proteins.  Contact ORTHO BIOTECH (1-888-2ASKOBI or

       1-888-227-5624) to perform assays for binding and neutralizing

       antibodies.  If erythropoietin antibody-mediated anemia is confirmed,

       PROCRIT should be permanently discontinued and patients should not be

       switched to other erythropoietic proteins.

    -- The safety and efficacy of PROCRIT therapy have not been established in

       patients with a known history of a seizure disorder or underlying

       hematologic disease (e.g., sickle cell anemia, myelodysplastic

       syndromes or hypercoagulable disorders).

    -- In some female patients, menses have resumed following PROCRIT therapy;

       the possibility of pregnancy should be discussed and the need for

       contraception evaluated.

    -- Prior to and regularly during PROCRIT therapy monitor iron status;

       transferrin saturation should be greater than or equal to 20% and

       ferritin should be greater than or equal to 100 ng/mL.  During therapy

       absolute or functional iron deficiency may develop and all patients

       will eventually require supplemental iron to adequately support

       erythropoiesis stimulated by PROCRIT.

    -- During PROCRIT therapy, blood pressure should be monitored carefully

       and aggressively managed, particularly in patients with an underlying

       history of hypertension or cardiovascular disease.

    -- In studies, the most common side effects included fever (pyrexia),

       diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or

       loss of strength or weakness (asthenia, fatigue), shortness of breath,

       high blood pressure, headache, joint pain (arthralgias), abnormal skin

       sensations (as tingling or tickling or itching or burning;

       paresthesia), rash, constipation and upper respiratory infection.


Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.

CONTACT: Kassy McGourty, +1-908-541-4090 office, +1-908-377-5873 cell,, for Ortho Biotech Products, L.P. kmcgourt@obius.jnj.com

Web site: http://www.orthobiotech.com/

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Posted: April 2008

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